FULL APPROVAL

MannKind wins FDA approval for Afrezza in children as young as 6

The approval, backed by the Phase 3 INHALE-1 trial, makes Afrezza the first inhaled mealtime insulin option for pediatric patients after a century of injection-based therapy.

By AppliedXLMay 29, 2026Trial NCT04974528

Executive Summary

The FDA approved MannKind's inhaled insulin for use in children and adolescents, resolving a supplemental biologics license application on the regulator's original target date with no delay.
The approval draws on a Phase 3 pediatric trial that compared the inhaled drug against standard injection therapy, plus safety and exposure data accumulated over two decades of adult use.
Children as young as 6 gain access to a mealtime insulin that does not require an injection, a delivery option that has not previously existed for this age group.
The approval extends an established drug into a population where every other insulin therapy identified in the same target class is delivered by injection, not inhalation.

The decision

The FDA approved Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 and older with type 1 and type 2 diabetes on May 29, 2026, MannKind announced. The agency reached its decision on the target action date it had set when it accepted the supplemental biologics license application (sBLA) the prior October, a Prescription Drug User Fee Act (PDUFA) deadline of May 29, 2026. MannKind first disclosed that date in October 2025 and repeated it across at least nine subsequent updates without change, and the approval landed on schedule. MannKind+1

Probability of Success

Endpoint Met82%

Completes100%

Clinical Significance19%

Regulatory14%

The evidence behind it

The approval rests on the Phase 3 INHALE-1 trial (NCT04974528), a 319-patient, open-label, randomized study in children and adolescents ages 4 to 17 with type 1 or type 2 diabetes. The 26-week trial compared Afrezza plus basal insulin against multiple daily injections (MDI) plus basal insulin, then extended the design so remaining MDI patients switched to Afrezza for a further 26 weeks. MannKind reported six-month topline results in December 2024 and said the submission also carried safety data from the extension phase. “With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day, while offering a needle-free mealtime option,” said Desmond Schatz, professor of pediatrics at the University of Florida College of Medicine. NCT04974528+2

What the label covers

The approved indication covers children and adolescents aged 6 and older with type 1 or type 2 diabetes, narrower than the trial's enrollment window of ages 4 to 17. Afrezza was first approved for adults in 2014 and is also approved in India and Brazil; it is recognized in the American Diabetes Association's Standards of Care. “For more than a century, insulin therapy for children living with diabetes has largely meant multiple daily injections,” said Michael Castagna, MannKind's chief executive. MannKind+2

Competitive position

Among the direct comparators identified in insulin-receptor agonist trials for type 1 and type 2 diabetes, every named program delivers insulin by injection rather than inhalation. Afrezza's inhaled route through MannKind's Technosphere platform is the differentiator against that field: the mechanism, activating the insulin receptor, is shared, but the route removes the needle. That trade-off is the premise the pediatric label now tests in practice, since the trial measured glycemic control against injections rather than against another inhaled comparator, because none exists in this indication. MannKind+1

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.